OTC Medication Information: NuHydraShield 30 SPF-30 Sunscreen

NUHYDRASHIELD 30 SPF-30 SUNSCREEN- octisalate, octocrylene and avobenzone cream
NuCare Pharmaceuticals,Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS:

ACTIVE INGREDIENTS

Octisalate 5.00%
Octocrylene 5.00%
Avobenzone 3.00%

Purpose

Sunscreen

USES:

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS:

  • For external use only.

Do not use

  • on damaged or broken skin.

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and consult physician

  • if irritation or rash develops.

Keep out of reach of children.

  • If product is swallowed, get medical attention or contact poison control center immediately.

DIRECTIONS:

  • Apply liberally 15-minutes before sun exposure.
  • Reapply:

- At least every two-hours.
- Immediately after swimming, sweating or towel drying.

SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

- Limit time in the sun, especially between 10am and 2pm.
- Wear long sleeve shirts, pants, hats and sunglasses.
- For children under 6-months, consult a physician.

OTHER INGREDIENTS:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Daucus Carota Sativa (Carrot) Extract, Hyaluronic Acid, Isostearyl Palmitate, Laureth-7, Parfum (fragrance), Phenoxyethanol,
Polyacrylamide, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, Sodium PCA, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Triethanolamine.

OTHER INFORMATION:

  • Protect this product from excessive heat and direct sunlight.

Package Labeling:

Label
(click image for full-size original)

NUHYDRASHIELD 30 SPF-30 SUNSCREEN
octisalate, octocrylene, avobenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70859-052
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 50 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
ALLANTOIN
ALOE VERA LEAF
WATER
ARGAN OIL
SHEA BUTTER
ALKYL (C12-15) BENZOATE
C13-14 ISOPARAFFIN
GREEN TEA LEAF
MEDIUM-CHAIN TRIGLYCERIDES
CAPRYLYL GLYCOL
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
COCONUT OIL
CYCLOMETHICONE 5
CYCLOMETHICONE 4
CARROT
HYALURONIC ACID
ISOSTEARYL PALMITATE
LAURETH-7
PHENOXYETHANOL
POLYSORBATE 20
POMEGRANATE
VITAMIN A PALMITATE
SACCHARIDE ISOMERATE
SODIUM PYRROLIDONE CARBOXYLATE
.ALPHA.-TOCOPHEROL ACETATE
TRIDECYL SALICYLATE
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70859-052-01 120 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/10/2019
Labeler — NuCare Pharmaceuticals,Inc. (010632300)

Revised: 09/2019 NuCare Pharmaceuticals,Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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