OTC Medication Information: Earth Mama Kids Uber-Sensitive Mineral Sunscreen SPF 40

EARTH MAMA KIDS UBER-SENSITIVE MINERAL SUNSCREEN SPF 40- zinc oxide cream
Earth Mama Angel Baby, LLC

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 Ingredient

Zinc Oxide 25%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions ), decreases 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 ask a doctor if

  • rash occurs

Keep out of reach of children. If

product is swallowed, get medical help

or contact Poison Control Center right

away.

Directions

  • Apply generously and evenly to all skin exposed to sun 15 minutes before sun exposure
  • Children under 6 months of age: ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. — 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • Reapply
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

Other Information

  • Protect the product in this container from exessive heat and direct sun.

Inactive Ingredients Cocos Nucifera

(Coconut) Oil*, Cocos nucifera (Fractionated

Coconut) Oil*, Cera Alba (Beeswax)*, Olea Europaea

(Olive) Fruit Oil*, Rubus Idaeus (Red

Raspberry) Seed Oil*, Simmondsia Chinensis

(Jojoba) Oil*, Butyrospermum Parkii (Shea) Butter*,

Oryza Sativa (Rice) Bran Oil*, Tocopherol, Avena

Sativa (Oat) Kernel Flour*, Aloe Barbadensis Leaf Juice (Aloe Vera)*,

Calendula Officinalis (Calendula) Flower Extract*

*Organic

Questions or comments?

503-607-0607 or earthmamaorganics.com

earth

mama

KIDS

Uber-Sensitive Mineral

Sunscreen Lotion

Broad Spectrum SPF 40

Pediatrician Tested

Dermatologist tested and

clinically tested for irritation

Water Resistant (40 Minutes)

UVA/UVB Protection

Contains Organic Shea Butter

& Organic Colloidal Oatmeal

NSF

contains organic ingredients

Non-Nano, NO Parabens,

NO Artificial Fragrance

Net Wt 84 g (3 oz)

SPF

40

Label
(click image for full-size original)

EARTH MAMA KIDS UBER-SENSITIVE MINERAL SUNSCREEN SPF 40
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72812-148
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 250 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
COCONUT OIL
MEDIUM-CHAIN TRIGLYCERIDES
YELLOW WAX
OLIVE OIL
RUBUS IDAEUS SEED
JOJOBA OIL
SHEA BUTTER
RICE BRAN OIL
TOCOPHEROL
OATMEAL
ALOE VERA LEAF
CALENDULA OFFICINALIS FLOWER
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72812-148-01 84 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final M020 04/01/2019 07/31/2025
Labeler — Earth Mama Angel Baby, LLC (603560686)
Establishment
Name Address ID/FEI Operations
Cosmetic Solutions, LLC 807907928 manufacture (72812-148)

Revised: 09/2023 Earth Mama Angel Baby, LLC

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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