VACATION SPF 30 BABY OIL- avobenzone, homosalate, octisalate, octocrylene oil

Vacation SPF 30 Baby Oil by

Drug Labeling and Warnings

Vacation SPF 30 Baby Oil by is a Otc medication manufactured, distributed, or labeled by Vacation Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone (2.8%)

Homosalate (9.8%)

Octisalate (4.9%)

Octocrylene (9.5%)

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 ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours

Use a water-resistant sunscreen if swimming or sweating.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses Children under 6 months of age: ask a physician.

INACTIVE INGREDIENT

Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Jasminum Officinale (Jasmine) Extract, Methyl Dihydroabietate, Polyester-8, Rosa Canina (Rose) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Trimethylpentanediol/ Adipic Acid/Glycerin Crosspolymer

Other Information

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VACATION SPF 30 BABY OIL 
avobenzone, homosalate, octisalate, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.8 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ROSA CANINA SEED OIL (UNII: MHT97MG5P8)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
SAFFLOWER OIL (UNII: 65UEH262IS)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-011-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2023
2	NDC: 80641-011-03	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2023

Labeler - Vacation Inc. (117644631)