SPF 30 SUNSCREEN WITH SOYBEAN- octinoxate, octisalate, oxybenzone, titanium dioxide spray, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)

Available from:

Tekweld Solutions, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

• Helps prevent sunburn

Authorization status:

OTC monograph not final

Summary of Product characteristics

SPF 30 SUNSCREEN WITH SOYBEAN- OCTINOXATE, OCTISALATE, OXYBENZONE,
TITANIUM
DIOXIDE SPRAY, SUSPENSION
TEKWELD SOLUTIONS, 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._
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SPF 30 SUNSCREEN SPRAY WITH SOYBEAN OIL
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Octinoxate 7.5%,
Octisalate 5.0%,
Oxybenzone 2.0%
Titanium Dioxide 2.5%
Soybean oil 3%
_PURPOSE_
Sunscreen
_USES_
• Helps prevent sunburn
_WARNINGS:_
SKIN CANCER/SKIN AGING ALERT: Spending time in the sun increase your
risk of skin cancer and early skin
aging.
This products has been shown only to prevent sunburn, not skin cancer
or early skin aging.
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 swallowed, get medical help or contact a Poison Control
Center right away.
_DIRECTIONS_
Apply generously & evenly before sun exposure.Reapply as needed or
after towel drying, swimming,
or sweating. Ask doctor before using on children under 6 months.
_OTHER INFORMATION_
Protect this product from excessive heat and direct sun
_INSECT REPELLENT ACTIVE INGREDIENT: SOYBEAN OIL 3% _
_INACTIVE INGREDIENTS_
Water, Microcrystalline cellulose, C12-15 Alkyl Benzoate, Isooctyl
Palmitate, Propylene
Glycol, Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl
Butylcarbamate, DMDM Hydantoin,
Fragrance.
_DRUG QUESTIONS:_
877-254-2281
DISTRIBUTED BY:
Tekweld: 45 Rabro Drive, Hauppauge, NY11788
PACKAGE LABELING:
SPF 30 SUNSCREEN WITH SOYBEAN
octinoxate, octisalate, oxybenzone, titanium dioxide spray, suspension
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7116 0 -0 10
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7M