ALMAY HEALTHY BIOME MAKEUP- homosalate, octisalate, octocrylene, titanium dioxide, zinc oxide emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)

Available from:

Almay

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Helps prevent sunburn. if used as directed with other sun protection measures descreases the risk of skin cancer and early skin aging caused by the sun.

Authorization status:

OTC monograph final

Summary of Product characteristics

ALMAY HEALTHY BIOME MAKEUP- HOMOSALATE, OCTISALATE, OCTOCRYLENE,
TITANIUM DIOXIDE,
ZINC OXIDE EMULSION
ALMAY
_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._
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ALMAY SKIN PERFACTING HEALTHY BIOME MAKEUP
ACTIVE INGREDIENT SECTION
Homosalate 5.0%
Octisalate 5.0%
Octocrylene 5.0%
Titanium Dioxide 5.8%
Zinc Oxide 3.94%
US ES
Helps prevent sunburn. if used as directed with other sun protection
measures descreases the risk of
skin cancer and early skin aging caused by the sun.
WARNINGS
For external use only
Do not use on danaged skin or broken skin
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 10am- 2pm.
Wear long-sleeved shrirts, pants, hats and sunglasses.
WHEN USING THIS PRODUCT
Keep out of the eyes, Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
KEEP OUT OF REACH OF CHILDREN
If product is swalled get medical help or contact a Poison Control
Center right away.
DIRECTIONS
Apply liberally 15 minutes before sun exposure. Use water resistant
sunscreen is swimming or
sweating. Repply at least ever 2 hours. Children under 6 months; Ask a
doctor.
ALMAY HEALTHY BIOME MAKEUP
homosalate, octisalate, octocrylene, titanium dioxide, zinc oxide
emulsion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 311-0 723
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)
HOMOSALATE
5 mg in 1 mL
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)
OCTISALATE
5 mg in 1 mL
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
3.9 4