OTC Medication Information: ChapIce SPF 30 Lip Balm

CHAPICE SPF 30 LIP BALM- octinoxate, oxybenzone, octocrylene and octisalate stick
OraLabs

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.

Active ingredient

Octinoxate (7.5%), Octocrylene (10.0%), Oxybenzone (5.0%), Octisalate (5.0%)

Purpose

Sunscreen, Sunscreen, Sunscreen, Sunscreen

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Uses

Prevents Sunburns

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Mineral Oil, Ozokerite, Petrolatum, Microcrystalline Wax, Ceresin, Flavor, Copernicia Cerifera (Carnauba) Wax, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Stearic Acid, Tocopheryl Acetate, Aluminum Hydroxide.

Package/Label Principal Display Panel

Front and Back of SPF 30 Combo Card -- Berry
(click image for full-size original)
CHAPICE SPF 30 LIP BALM
octinoxate, octocrylene, oxybenzone, octisalate stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63645-163
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mg in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 5.0 mg in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10.0 mg in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 5.0 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM 13.0 mg in 1 g
LIGHT MINERAL OIL 25.5 mg in 1 g
.ALPHA.-TOCOPHEROL ACETATE .1 mg in 1 g
CERESIN 36 mg in 1 g
MICROCRYSTALLINE WAX 4 mg in 1 g
Product Characteristics
Color WHITE Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63645-163-01 1 g in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/09/2017
Labeler — OraLabs (801824756)
Registrant — OraLabs (801824756)
Establishment
Name Address ID/FEI Operations
OraLabs 801824756 MANUFACTURE (63645-163), LABEL (63645-163)

Revised: 11/2022 OraLabs

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.

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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